Phase 1B2A Study of ALD-102 Solution Injections for Safety and Hair Regrowth in Adults with Alopecia Areata

What this Trial Is About

Researchers are evaluating ALD-102 Solution in adults with alopecia areata to determine its safety, tolerability, and effect on hair regrowth. This first-in-human clinical trial compares ALD-102 injections in the scalp to placebo injections and untreated areas. The study aims to understand treatment-related side effects and hair regrowth outcomes in affected scalp areas. Participants receive injections of ALD-102 Solution or placebo once every 4 weeks over an 8-week treatment period. Different scalp areas are selected for treatment, placebo, or no treatment depending on the cohort. The study includes multiple injections per treatment area, with dosing adjusted by cohort. This randomized, triple-blind study monitors participants for adverse effects and drug levels. Throughout the trial, participants undergo clinical assessments, local tolerability evaluations, and safety monitoring for 24 weeks. Skin biopsies and blood samples are collected to measure ALD-102 concentrations. Researchers track hair regrowth and adverse events using standardized scales and assessments. Participants are required to follow study procedures and maintain consistent hair styling during the study duration.

A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata